Ophthalmic Alginate Composition Related Methods of Manufacture and Methods of Use

Abstract

The present invention is directed to an ophthalmic composition comprising alginate having a minimum of about 0% and a maximum of about 50% guluronic units bound to an adjacent guluronic unit as a percentage of the total number of monomeric units in the alginate. The composition further includes a cationic antimicrobial agent. The alginate set forth above forms less deactivating complexes with cationic antimicrobial agent, and thus, the composition has improved preservative efficacy.

1 . A dry eye composition comprising an aqueous solution of alginate having a minimum of about 10% and a maximum of about 40% guluronic units bound to an adjacent guluronic unit as a percentage of the total number of monomeric units and a cationic antimicrobial agent. 
     
     
         2 . The dry eye composition of  claim 1 , wherein the alginate is from  Lessonia nigrescens  seaweed. 
     
     
         3 . The dry eye composition of  claim 1 , further comprising a polyol that is a combination of glycerin and propylene glycol. 
     
     
         4 . The composition of  claim 1 , wherein the alginate has a concentration that is a minimum of about 0.01 wt. % to about 5 wt. % based upon the total weight of the solution. 
     
     
         5 . The composition of  claim 1 , further comprising a polyol selected from the group consisting of glycerin, ethylene glycol, poly(ethylene glycol), propylene glycol, sorbitol, manitol and monosaccarides, disaccharides, neutral polysaccharides and oligosaccharides. 
     
     
         6 . The composition of  claim 1 , wherein the cationic antimicrobial agent is selected from the group consisting of poly(hexamethylene biguanide), Alexidine, chlorhexidine, polyquaternium-1, polyquaternium-10, ammonium salts of guar, ammonium salts of chitosan, and combinations thereof. 
     
     
         7 . The composition of  claim 1 , wherein the cationic antimicrobial agent is Alexidine. 
     
     
         8 . A method of treating dry eye comprising administering to an eye a composition comprising an aqueous solution of alginate having a minimum of about 10% and a maximum of about 40% guluronic units bound to an adjacent guluronic unit as a percentage of the total number of monomeric units in the alginate and a cationic antimicrobial agent. 
     
     
         9 . The method of  claim 8 , wherein the composition further comprises a polyol. 
     
     
         10 . The method of  claim 8 , wherein the alginate has a concentration that is a minimum of about 0.01 wt. % and a maximum of about 5 wt. % based upon the total weight of the composition. 
     
     
         11 . The method of  claim 8 , wherein the composition further comprises a polyol selected from the group consisting of glycerin, ethylene glycol, poly(ethylene glycol), propylene glycol, sorbitol, manitol and monosaccarides, disaccharides, neutral polysaccharides and oligosaccharides. 
     
     
         12 . The method of  claim 8 , wherein the composition has an osmolality that is a minimum of about 200 and a maximum of about 400. 
     
     
         13 . The method of  claim 8 , wherein the polyol comprises a combination of glycerin and propylene glycol. 
     
     
         14 . The method of  claim 14 , wherein the cationic antimicrobial agent is selected from the group consisting of poly(hexamethylene biguanide), Alexidine, chlorhexidine, polyquatemium-1, polyquaternium-10, quaternary ammonium salts of guar, quaternary ammonium salts of chitosan, and combinations thereof. 
     
     
         15 . The method of claim  18 , wherein the cationic antimicrobial agent is Alexidine. 
     
     
         16 . The method of  claim 8 , wherein the cationic antimicrobial agent is polyquaternium-1 or polyquaternium-10. 
     
     
         17 . A method of manufacturing an ophthalmic composition comprising combining in an aqueous solution ophthalmically pure alginate having a minimum of about 0% and a maximum of about 50% guluronic units bound to an adjacent guluronic unit as a percentage of the total number of monomeric units, and a cationic antimicrobial agent.